MAUDE Adverse Event Report: BOSTON SCIENTIFIC FLEXTOME CUTTING BALLOON

Model Number CB03350100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 02/08/2016

Event Type  Injury  

Event Description

Cutting balloon was detached from shaft of balloon.It was caught in filter distal wire distal to balloon.When the filter wire was pulled back and attempt to retrieve with snare.It also detached from wire.Reason for use: peripheral disease.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: FLEXTOME CUTTING BALLOON
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5433959
• MDR Text Key: 38247544
• Report Number: MW5060139
• Device Sequence Number: 1
• Product Code: NWX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CB03350100
• Device Lot Number: 17530310
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 98 YR
• Patient Weight: 65